Step 1 — Discover & Configure
(Week 1)
Map workflows, roles, and controls tailored to your operating model.
Includes:
- Requirements assessment
- Process mapping
- Initial configuration
Compliance Intelligence Platform
From Quality Records to Compliance Intelligence
Complere connects your quality records, actions, people, and evidence into one visible operating system—so you don't just pass audits, you understand and control quality in real time.
Validation-ready foundation
Connected traceability
Built for inspections
Records Actions People Evidence Real-time visibility Decision-ready control
Built for quality leaders who need control, visibility, and inspection confidence across regulated operations.
Designed for teams that cannot afford fragmented quality execution
- 21 CFR Part 11–friendly
- Immutable audit trails
- No hard deletion
- Regional data residency
Faster onboarding, earlier value
Go Live in Weeks, Not Months
Guided rollout with real workflows—reach usable, auditable outcomes in record time.
Step 2 — Operate & Validate
(Weeks 2–4)
Run live workflows to validate traceability and readiness for compliance.
Includes:
- Workflow execution
- User training & enablement
- Validation activities
Step 3 — Review & Go-Live
(Week 5)
Confirm readiness, finalize production rollout, and provide hypercare.
Includes:
- IQ/OQ readiness
- Stakeholder sign-off
- Controlled rollout + hypercare
Pilot-led implementation
Real-world validation
Inspection-ready outcomes faster
Pilot
Validate in Your Environment
See traceability, usability, and inspection readiness using your processes.
Typical pilot: 4–6 weeks depending on scope and data readiness.
Validation-ready foundation
CSV and CSA — Without Overhead
Apply the right level of validation rigor based on risk—without slowing adoption.
CSV
Structured validation
Documented IQ/OQ/PQ evidence, traceable requirements, and release discipline aligned to how QA and IT qualify systems.
CSA
Risk-based assurance
Focus testing on what matters for patient safety, product quality, and data integrity—while keeping records inspection-defensible.
RBAC
Controlled access and approvals by role, site, and function.
Audit trails
Time-stamped, immutable history for governed changes.
Version diffs
Before-and-after visibility for documents and critical records.
No deletion
Restore with audit context instead of silent data loss.
Built by teams who have lived through inspections
Complere is shaped by people with direct experience in pharmaceutical quality operations, medical device compliance, and GxP validation — not generic enterprise software marketing.
Experience
25+ years combined regulated-industry experience
Across pharmaceutical manufacturing, biotech, medical devices, and life sciences quality operations — including inspection support, deviations, and validation programmes.
Community
ISPE, PDA, ASQ & GAMP-aligned practice
We engage with the same professional communities and guidance frameworks — GAMP 5, data integrity, and computerized systems — that quality and IT leaders use to qualify vendors.
Deployment
CSV validation package included
VMP, URS, risk assessment, and IQ/OQ/PQ templates ship with deployment — structured for regulated rollout, not sold as a separate line item.
Outcome
Faster audit response
Teams report shorter retrieval time for SOPs, training records, and CAPA chains when asked to show evidence during audits or customer QA reviews.
Deployment
Phased validation path
Structured IQ/OQ/PQ alignment with documented roles, plus support for release impact when the platform or configuration changes.
Collateral
Validation & compliance depth
Review the validation approach and Annex 11 validation playbook before your formal assessment.
Proof from regulated implementations
Anonymized examples illustrate typical scope, timeline, and measurable benefits — your account team can share sector-relevant detail during qualification.
Pharmaceutical · EU & US
Multi-site document & training alignment
Scope: document control, training, CAPA, change control.
Timeline: pilot in one site, multi-site rollout in phases.
Outcome: consolidated audit trail for procedures and training evidence; fewer overdue training findings in internal audits.
Biotech · clinical supply
Inspection-ready quality events
Scope: deviations, CAPA, supplier quality linkage.
Timeline: core workflows live before pivotal trial supply milestones.
Outcome: traceable investigation records and effectiveness checks for regulatory file readiness.
Medical device · Class II
Design-change traceability
Scope: change control, document control, training.
Timeline: aligned with design transfer window.
Outcome: linked change records, updated procedures, and training completion before product release.
Our Quality Modules And Their Capabilities
Connected quality modules spanning the full quality lifecycle—each with the core features that keep your system inspection-ready and practical for regulated teams.
Document Control
Control SOPs, forms, templates, and approvals without relying on shared drives.
- Role-based approval routing
- Controlled prints and download logging
- Structured metadata and folder governance
- Link documents to CAPA, training, and change
- Keep one approved source of truth
FDA 21 CFR Part 11
Electronic Signatures
EU GMP Annex 11
Explore Document Control
CAPA & Deviations
Close the loop from issue intake through investigation, action, and effectiveness verification.
- Deviation and event capture
- Root cause and action planning
- Connect to documents, risk, and audits
- Escalations and sign-off
- Reduce CAPA cycle time
FDA 21 CFR Part 11
Electronic Signatures
EU GMP Annex 11
Explore CAPA & Deviations
Audit Management
Plan internal, supplier, and site audits with evidence, findings, and follow-up in one flow.
- Audit calendars and scope templates
- Observation capture and classification
- CAPA and document linkage
- Inspection confidence views
- Keep the audit program visible
FDA 21 CFR Part 11
Electronic Signatures
EU GMP Annex 11
Explore Audit Management
Training & Competency
Show that people are trained, current, and assigned work that matches their role.
- Role-based curricula
- Online and offline evidence
- Competency dashboards
- Linked procedural change
- Explain role qualification clearly
FDA 21 CFR Part 11
Electronic Signatures
EU GMP Annex 11
Explore Training & Competency
Change Control
Move proposed changes through impact assessment, approval, implementation, and verification.
- Request and approval routing
- Linked document and training effects
- Implementation evidence capture
- Connection to CAPA and risk
- See impact before execution
FDA 21 CFR Part 11
Electronic Signatures
EU GMP Annex 11
Explore Change Control
Management Review
Give leadership one repeatable frame for quality performance, escalations, and improvement decisions.
- Standard review sections
- Connected KPIs and trend summaries
- Decision tracking
- Inspection-ready review trail
- Review what matters every cycle
FDA 21 CFR Part 11
Electronic Signatures
EU GMP Annex 11
Explore Management Review
Risk Assessments
Structure risk assessments across products, processes, and quality events with scored, traceable records.
- Risk identification and scoring matrix
- Severity, probability, and detectability weighting
- Link risks to CAPA, change, and audit findings
- Periodic review and residual risk sign-off
- Inspection-ready risk history
ICH Q9
ISO 14971
FDA 21 CFR Part 11
Explore Risk Assessments
Built for Regulatory Inspection Readiness
Every module includes built-in controls that support continuous compliance and defensible inspection readiness.
FDA 21 CFR Part 11
Electronic Signatures
ISO 13485 Aligned
EU GMP Annex 11
100%Audit Trail Coverage
21 CFRPart 11 Aligned
ISO 13485Aligned System
Your Path to Quality Excellence
A staged, low-disruption path from your current state to a fully governed, inspection-ready quality system.
01
Discovery & Planning
Requirements assessment, process mapping, and first-scope planning.
2-4 weeks02
Configuration & Setup
Workflow setup, role configuration, and controlled deployment prep.
4-6 weeks03
Training & Validation
User enablement, qualification activities, and acceptance checks.
3-4 weeks04
Go-Live & Support
Production rollout, hypercare support, and staged expansion.
OngoingStart From Where You Are
Whether you are leaving paper processes, retiring spreadsheets, or replacing a legacy eQMS — Complere provides a clear path forward.
Transformation Journey
Moving from paper, spreadsheets, or a legacy eQMS
Structured migration paths that address your current-state risk, define the rollout approach, and measure the outcome — without a multi-year programme.
Explore this path
Operational Outcome
Achieving audit readiness, quality visibility, and traceability
Leadership-focused outcome pages that explain how Complere addresses the quality goals that matter most — inspection confidence, team accountability, and cross-site consistency.
Explore this pathWhat Quality Teams Gain
Regulated organizations across pharmaceutical, medical device, and life sciences use Complere to stay inspection-ready and operationally efficient.
CAPA and Deviation Resolution
Structured intake, clear ownership, and escalation controls reduce time spent chasing open actions across email threads.
Document Approval and Release
Parallel review routing and electronic signatures replace sequential bottlenecks and shared-drive confusion.
Training Completion and Compliance
Automated assignments linked to document updates keep training records current and inspection-ready without manual tracking.
Purpose-Built for Regulated Industries
Whether you work in pharmaceutical manufacturing, medical devices, nutraceuticals, or contract research, Complere is configured for the specific compliance requirements of your sector.
Industry
Pharmaceutical Manufacturing
Support GMP-centric quality operations across manufacturing, QA, validation, and release functions.
Learn moreIndustry
Medical Devices
Connect design, risk, CAPA, training, and document control for device-focused quality systems.
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Healthcare & Laboratories
Bring quality documentation, training, investigations, and review cadence into one controlled operating model.
Learn moreIndustry
Nutraceuticals & Supplements
Standardize documents, deviations, training, and supplier-facing quality work in a growing regulated environment.
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CMO / CDMO
Coordinate quality work across internal teams, customers, and partner sites with stronger visibility and accountability.
Learn moreIndustry
Clinical Research & CROs
Bring controlled processes, training evidence, and follow-up visibility into distributed research operations.
Learn moreRelated Resources
Explore related modules, compliance topics, and guides to build a complete picture of your quality system.
See how Complere can bring your quality operations under control
Schedule a guided demo focused on your workflows and compliance requirements, or start with a focused 30-day pilot.